Kailera Therapeutics, Inc.
AssociateDirector,StatisticalProgramming
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“Associate Director, Statistical Programming at Kailera Therapeutics, Inc.. Skills: Statistical Programming, SAS, CDISC, Regulatory Submissions. Lead statistical programming efforts. development and review of programming specifications”
What You'll Achieve.
ensure clarity; integrity; compliance with internal and external standards; deliver results in a timely and accurate manner
Industry & Context.
support emerging clinical questions; internal decision-making
What They're Looking For.
Must Have
Proven hands-on experience in programming for clinical development, Experience in regulatory submissions, Expertise in SAS programming, comprehensive knowledge of CDISC standards, Familiarity with ICH/GCP guidelines, global regulatory submission requirements, Extensive experience overseeing CROs, independent validation of datasets, statistical deliverables
Nice to Have
preference for late-phase clinical trial support, experience in ISS/ISE highly desirable, Background in cardiometabolic diseases or related therapeutic areas
What You'll Do.
Lead statistical programming efforts
development and review of programming specifications
execution of ad-hoc and post-hoc analyses
Oversee and coordinate activities with CROs
Conduct independent validation
quality checks of statistical programming deliverables
Collaborate closely with statisticians
Manage multiple projects simultaneously
How You'll Work.
Team & Collaboration
Collaborate closely with statisticians; cross-functional study teams
Process & Methodology
Manage multiple projects simultaneously, tasks prioritized effectively, meet deadlines
Full Job Description
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: We are seeking an experienced programmer to join us as Associate Director, Statistical Programming. This is a critical role responsible for leading statistical programming activities on the assigned disease area(s). This role will support clinical trials, regulatory submissions, and other key initiatives. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) Responsibilities: Lead statistical programming efforts for clinical studies, including the development and review of programming specifications to ensure clarity, integrity, and compliance with internal and external standards Lead the execution of ad-hoc and post-hoc analyses to support emerging clinical questions, publications, and internal decision-making Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables Conduct independent validation and quality checks of statistical programming deliverables from CROs Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines Required Qualifications: Proven hands-on experience in programming for clinical development, preferably in a
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